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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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iATP PAS


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General
Study Status Progress Adequate
Application Number P010031 S674/ PAS001
Date Current Protocol Accepted  
Study Name iATP PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description To further characterize iATP effectiveness in real world clinical practice to pace-terminate VT. The study is a global, non-randomized, prospective post-market surveillance study.

Study Population Description Subjects with an implanted Cobalt ICD or CRT-D with iATP enabled and enrolled in the Medtronic CareLink Network.
Sample Size Approximately 2200 patients will be enrolled to review 241 eligible episodes.
Data Collection To demonstrate the effectiveness performance of iATP in the fast VT (FVT) zone is acceptable, i.e. iATP success rate is greater than 60%.



Secondary objectives:

¿To demonstrate the effectiveness performance of iATP in the FVT zone exceeds expectations, i.e., iATP success rate is greater than 70%

¿To characterize arrhythmia-related syncope events

¿To characterize unnecessary and inappropriate shocks

Follow-up Visits and Length of Follow-up 5 years


iATP PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/22/2020 10/21/2020 On Time
one year report 04/23/2021 04/22/2021 On Time
18 month report 10/22/2021    
two year report 04/23/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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